Intrauterine device



about 23 to about 25 millimeters.

United States Patent O M' 3,250,271 INTRAUTERINE DEVICE Jack Lippes, 64Curtis Parkway, Tonawanda, N.Y. Filed Apr. 29, 1963, Ser. No. 276,597 9Claims. (Cl. 12S-130) This invention relates to an intrauterine device,and more particularly to such a device useful for contraceptivepurposes.

It is a known medical fact that a foreign object in the uterus willprevent conception. Heretofore, different Y tion or in any other wayadversely affect the well-being of v .the wearer.

A further object is to provide such an intrauterine device any undesireddisplacement of which from the uterus following proper insertion thereincan be detected.

Still another object is to provide such an intrauterine device which issimple in construction, easy to manufacture and relatively inexpensive.

Other objects and advantages of the present invention will be apparentfrom the following detailed description of a preferred embodimentillustrated in the accompanying drawing in which:

, FIG. l is a side elevational view, partly in section, of

an instrument in operative position for inserting into a uterus theinventive intrauterine device, also shown in substantially straightenedout form and arranged on the instrument.

FIG. 2 is a view similar to FIG. 1 insofar as illustration of the uterusis concerned and showing the intrauterine device in operative positiontherewithin following its insertion and withdrawal of the aforesaidinserting instrument, a portion of the tail forming part of the devicewhich is cut olf following insertion being illustrated in broken lines.

FIG. is a side elevational view of the intrauterine device in theoperative sinuous configuration which it normally assumes, and showingthe critical dimensions of the isosceles trapezoid within whoseimaginary boundaries the device in its normal sinuous form is confined.

FIG. 4 is an enlarged transverse sectional view of the insertinginstrument with the intrauterine device arranged thereon and taken online 4 4 of FIG. i.

FIG. 5 is a left end elevational view of the intrauterine device shownin FIG. 3.

FIG. 6 is an enlarged sectional view thereof taken on line 6 6 of FIG.3.

The inventive intrauterine device is shown as comprising an elongated orbar-like body 1I) of tiexible material arranged in sinuous or serpentineform substantially in one plane within the imaginary boundaries of anisosceles trapezoid having a short boundary side 11, a parallel longside 12, and a pair of non-parallel boundary sides 13 and 14 of equallength. The dimensions of such sides are critical. The short side 11 hasa length falling in the range of from about 15 to about i8 millimeters.The long side 12 has a length falling in the range of from about 25 toabout 30 millimeters. Each of the non-parallel sides 13 and 14 has alength falling in the range of from As shown, the device Patented May10, 1966 has two nodes or reverse curves on each side of the body, thoseon the left being designed 13' and 13" and those on the right beingdesignated 14 and 14". Referring to FIG. 3, it will be noted that thesinuous body 10 is conlined entirely within the boundary sides 11-14 ofthe isosceles trapezoid, the boundary side 13 being tangent to the onepair of nodes 13 and 13" and the boundary side 14 being tangent to theother pair of nodes 14 and 14". These nodes are connected to progressfrom one end of the body 10 to the other end thereof successivelyreversing their directions of curvature. Thus, as viewed in FIG. 3,starting from the upper and large end of body 10 and moving toward thelower and small end thereof, node 13l curves in a counterclockwisedirection, node 14 in a clockwise direction, node 13" in acounterclockwise direction, and node 14 in a clockwise direction. Theterminal portions of bar-like body 10', one being the body part betweennode 13 and the adjacent free end and the other being the body partbetween node 14" and the adjacent free end, are severally contacted by aparallel boundary sides 11 and 12.

The body 10 may be round or non -round such as oblong in cross-sectionas shown in FIG. 6 andpreferably has a major dimension in cross-sectionof about 0.080 inch, and a length when straightened out of about 4.5inches.

The intrauterine device also comprises a thread-like tail 15 of flexiblematerial connected at one end to that end of the body 10 at the shortside 11 of the aforementioned trapezoid. Preferably, the tail 15 isprovided by inserting a length of a single thread through a hole 101 inthe end portion of the body 10 until about half the length of the threadhas passed through the hole. Then the two thread portions are tied intoa knot indicated at leaving two strands 151 and 152. However, a singlestrand tail may be used'and it may be suitably attached to the body 10other than by being tied thereto.

The tail 15 may be round or non-round in cross-section and is preferablysmaller in cross-section than the body` 16. The length of the tail 15 isabout 2.5 inches.

The intrauterine device may be made of any suitable flexible material.While the body portion 10i and the tail portion 15 may be made ofdifferent materials, it is preferred that they be made of the samematerial. It is preferred to make the device of polyethylene with thebody portion 1,0 composed of low density polyethylene and the tailportion 15 composed of linear polyethylene. Ihave found a surgicalthread having a thickness of about 0.007 inch particularly useful toprovide the tail. If a single strand tail is employed it may be moldedintegrally with or fused to the body of the device.

Regardless of what material the device is made of, it is essential thatthe body 10 provides a resilient member capable of being substantiallystraightened out and upon release thereafter returning to its sinuousform as illustrated. In the case of polyethylene, this can beconveniently achieved by molding the body 10 in its sinuous form so thatwhen straightened out, it has memory or a resistance to cold flow whichcauses it to return to its sinuous configuration.

Viewed in another manner, the inventive intrauterine device comprisesv abar-like body of flexible material curved in a substantially flat planein the shape of a large S continuing intoa smaller S, the body beingcapable of being substantially straightened out and upon release tendingto return to such continuous double S- curved shape.

If desired about 20% by volume of barium sulfate may be mixed with theplastic material to render devices molded therefrom visible to X-rayexamination.

The reason why the aforementioned resilient characteristic of the bodyportion 10 of the intrauterine device is important will now be apparentwhen the mode of inserting the device into an uterus is considered.

Referring to FIGS. 1 and 2, an uterus is represented at U having acavity 16 in the inner portion or fundus of the uterus whichcommunicates with the vagina (not shown) by a neck portion or isthmus17.

The inserting instrument represented generally by the numeral 18 isshown as comprising a sleeve or tube 19 and a plunger 20 freely slidablyarranged therein. The sleeve or tube 19 has a gradually turning orcurved inner portion as indicated at 21, and while it may be made of arigid material it is preferably made of a flexible plastic material suchas one of the long chain fluorinated polymers of ethylene such astetrauoroethylene, known under one'trademark as Teon. In cross section,the sleeve or tube 19 may be round, or non-round such as being oblong.

The plunger 20 is made of a flexible material since it must follow thecontour of the passage in the sleeve or tube 19, and is also preferablymade of Teflon. The cross-section of the plunger 20 correspondsgenerally to that of the sleeve or tube 19, expt that the plunger isprovided with a longitudinal groove 22.

In use of the instrument 18, the sleeve or tube 19 and plunger 20 arefirst separated. The body portion 10 of the intrauterine ldevice is thenfed into the sleeve or tube 19, with the free end remote from the tailportion 15 being inserted into the end of the sleeve or tube remote fromthe curved portion 21. In the course of so inserting the body portion10, it is straightened' out against its natural urging of assuming itssinuous form. When the body portion has been substantially completelyinserted within the sleeve or tube 19, the tail portion 15 is placed inthe groove 22 in the plunger 20, such groove being large enough toreceive the tail portion. The end of the plunger 20 adjacent thetrailing end of the straightened out body portion is then inserted intothe sleeve or tube 19. Partial insertion of the tail portion within thegroove y22 isv depicted in FIG. 1, in which the partial insertion of theplunger 20 within the sleeve or tube 191 is also illustrated. Theleading end of the plunger 20 thrustingly bears against the rearwardlyfacing shoulder 23 formed by the trailing end of the body portion 10 dueto the difference in thickness of the tail portion 15.

With the intrauterine device so arranged on the instrument 18, theassembly is inserted into the vagina (not shown) and partially into theuterine cavity 16 through the isthmus 17 as illustrated in FIG. l.Thereafter, the plunger 20 with the tail portion arranged within thegroove 22, is gradually pushed into the sleeve or tube 19.

As the body portion 10 enters the uterine cavity 16, it returns to itssinuous form, as shown in FIG. 2. The plunger 20, which is longer thanthe sleeve or tube 19, is continued to be pushed inwardly thereof untilthe entire body portion 10 is accommodated within the uterine cavity 16and the tail portion 15 is left extending through the isthmus 17.Thereafter the instrument 18 is Withdrawn and the portion of the tailextending outwardly of the isthmus 17 may be cut oi. Such cut-olfportion is shown at 15a inFIG. 2.

Instead of utilizing an inserting instrument for the intrauterine devicein which the plunger has a groove such as the groove 22, the plunger mayhave enough clearance between its periphery and the internal surface ofthe guide sleeve or tube as will accommodate the tail portion 15 of thedevice and still be freely slidable within the sleeve or tube.

Clinical studies have shown that the intrauterine device remains in theoperative position shown in FIG. 2 and does not rotatively move withinthe uterine cavity so as to draw thereinto the tail 15. The device maybe left within the uterus for months or years and will remain in itsoperative position during such time. In case it is desired to remove thedevice, this is readily accomplished by grasping the free end of thetail 15 with a suitable inl strument such as forceps (not shown) andthereafter gradually pulling the device outwardly of the uterus throughthe isthmus 17. In being so removed, the body portion 10 straightens outsubstantially to pass through the isthmus 17 without discomfort.

From the foregoing, it will be seen that the embodiment of the presentinvention illustrated accomplishes the various objects stated and isillustrative rather than limitative of the invention, the scope of whichis to be measured by the appended claims.

What is claimed is:

1. An` intrauterine device, comprising an elongated body arranged insinuous form in substantially one'plane withinthe imaginary boundariesof an isosceles trapezoid including a pair of opposite non-parallelboundary sides and a pair of opposite parallel boundary sides, suchsinuous body having a pair of nodes on each of two opposite sidesthereof and a terminal portion at each end, one of said non-parallelboundary sides being tangent to one node pair and the other of saidnon-parallel boundary sides being tangent to the other node pair,`saidnodes being connected to progress from one end of said body to the otherend thereof successively reversing their direc tions of curvature, saidparallel boundary sides severally contacting said terminal portions.

2. An intrauterine device, comprising an elongated body of exiblematerial arranged in sinuous form in substantially one plane within theimaginary boundaries of an isosceles trapezoid including oppositeparallel long and short boundary sides and a pair of oppositenonparallel boundary sides, such sinuous body having a pair of nodes ateach of two opposite sides thereof and a terminal portion at each end,one of said non-parallel boundary sides being tangent to one node pairand the other of said non-parallel boundary sides being tangent to theother node pair, said nodes being connected to progress from one end ofsaid body to the other end thereof successively reversing theirldirections of curvature, said parallel boundary sides severallycontacting said terminal portions, and a exible tail connected to thefree end of that terminal portion of said body at said short boundaryside of said trapezoid.

3. An intrauterine device, comprising an elongated body of flexiblematerial arranged in sinuous form in substantially one plane within theimaginary boundaries of an isosceles trapezoid having short, lon'g andnonparallel boundary sides, said short boundary side having a lengthfalling in the range of from about 15 to about 18 millimeters, said longboundary side having a length falling in the range of from about 25 toabout 30 millimeters and said non-parallel boundary sides severallyhaving a length falling in the range of from about 23 to about 25millimeters, such sinuous body having a pair of nodes on each of twoopposite sides thereof and a terminal portion at each end, one of saidnon-parallel boundary sides being tangent to one node pair and the otherof said non-parallel boundary sides being tangent to the other nodepair, said nodes being connected to progress from one end of said bodyto the other end thereof successively reversing their directions ofcurvature, said parallel boundary sides severally contacting saidterminal portions.

4. An intrauterine device, comprising an elongated body of exiblematerial arranged in sinuous form in substantially one plane within theimaginary boundaries of an isosceles trapezoid having short, long andnonparallel boundary sides, said short boundary side having a lengthfalling in the range of `from about 15 to about 18 millimeters, saidlong boundary side having a length falling in the range of from about 25to about 30 millimeters and said non-parallel boundary sides severallyhaving a length falling in the range of from about 23 to about 25millimeters, such sinuous body having a pair of nodes on each of twoopposite sides thereof and a terminal portion at each end, one of saidnon-parallel boundary sides being tangent to the one node pair and theother of said non-parallel boundary sides being tangent to the othernode pair, said nodes being connected to progress from one end of saidbody to the other end thereof successively reversing their directions ofcurvature, said parallel boundary sides severally contacting saidterminal portions, and a flexible tail connected to the free end of thatterminal portion of said body at said short boundary side of saidtrapezoid.

5. An intrauterine device, comprising a bar-like body of exible materialarranged in sinuous form in substantially one plane to provide aresilient member conned within the imaginary boundaries of an isoscelestrapezoid having short, long and non-parallel boundary sides, saidshortboundary side having a length falling in the range of from about l5 toabout 18 millimeters, said long boundary side having a length falling inthe range of from about 25 to about 30 millimeters and said nonparallelboundary sides severally having a length falling in the range of fromabout 23 to about 25 millimeters, said member when in said sinuous formhaving a pair of nodes on each of two opposite sides thereof and aterminal portion at each end, one of said non-parallel boundary sidesbeingtangent to one node pair and the other of said non-parallelboundary sides being tangent to the other node pair, said nodes beingconnected to progress from one end of said body to the other end thereofsuccessively reversing their directions of curvature, said parallelboundary sides severally contacting said terminal portions, said memberbeing capable of being substantially straightened out and upon releasethereafter returning to said sinuous form on its own.

6. An intrauterine device, comprising a bar-like body of exible materialarranged in sinuous form in substantially one plane to provide aresilient member confined within the imaginady boundaries of anisosceles trapezoid having short, long and nonaparallel boundary sides,said short boundary side having a length falling in the range of fromabout to 18 millimeters, said long boundary side having a length fallingin the range of from about 25 to 30 millimeters and said non-parallelboundary sides severally having a length falling in the range of fromabout 23 to about 25 millimeters, said member when in said sinuous formhaving a pair of nodes on each of two opposite sides thereof and aterminal portion at each end, one of said non-parallel boundary sidesbeing tangent to one node pair and the other of saidnon-parallel'boundary sides being tangent to the other node pair, saidnodes being connected to progress from one end of said body to the otherend thereof successively reversing their directions of curvature, saidparallel boundary sides severally contacting said terminal portions,4said member being capable of being substantially straightened out andupon relief thereafter returning to said sinuous form on its own, and aexible thread-like tail connected to the free end of that terminalportion of said body at said short boundary side of said trapezoid.

7. An intrauterine device as set forth in claim 5 wherein said memberwhen substantially straightened out `has a length of about 4.5 inches.

8. An intrauterine devices, comprising a bar-like body of llexiblematerial curved in a substantially fiat plane in the shape of a large Scontinuing into a smaller S, said body being capable of beingsubstantially straightened out and upon release thereafter .tending toreturn to such continuous double S-curved shape.

9. An intrauterine device, comprising a bar-like body of flexiblematerial curved in a substantially flat plane in the shape of a large Scontinuing into a smaller S, said body being capable of beingsubstantially straightened out and upon release thereafter tending toreturn to such continuous double S-curved shape, said body adjacent thefree end of such smaller S-shaped portion having a hole, and a threadpassing through said hole and tied into a knot intermediate its ends toprovide a two-strand tail.

References Cited bythe Examiner UNITED STATES PATENTS 328,553 10/1885Warmoth 128-127 662,716 11/1900 Gaedeke 12S-130 1,896,071 2/1933 Clark128--130 2,176,559 10/1939 Meckstroth 128-130 2,756,752 7/1956 Scherlis12S-303 3,200,815 8/1965 Malrguiles 12B-130 RICHARD A. GAUDET, PrimaryExaminer. D. L. TRULUCK, Assistant Examiner.

1. AN INTRAUTERINE DEVICE, COMPRISING AN ELONGATED BODY ARRANGED INSINUOUS FORM IN SUBSTANTIALLY ONE PLANE WITHIN THE IMAGINARY BOUNDARIESOF AN ISOSCELES TRAPEZOID INCLUDING A PAIR OF OPPOSITE NON-PARALLELBOUNDARY SIDES AND A PAIR OF OPPOSITE PARALLEL BOUNDARY SIDES, SUCHSINUOUS BODY HAVING A PAIR OF NODES ON EACH OF TWO OPPOSITE SIDESTHEREOF AND A TERMINAL PORTION AT EACH END, ONE OF SAID NON-PARALLEBOUNDARY SIDES BEING TANGENT TO ONE NODE PAIR AND THE OTHER OF SAIDNON-PARALLEL BOUNDARY